Doctors often prescribe statin drugs to lower cholesterol levels and reduce the risk of coronary artery disease. These drugs, which interfere with the liver's production of cholesterol, are relatively safe for most people but sometimes can cause muscle problems known as statin-associated myalgia (SAM). Some patients who cannot tolerate statins because of muscle problems use the dietary supplement red yeast rice as a cholesterol-lowering alternative. In light of previous findings that red yeast rice can reduce levels of low-density lipoprotein (LDL, or “bad” cholesterol), researchers from the University of Pennsylvania and Thomas Jefferson University investigated the effects of this supplement in patients with high cholesterol and a history of SAM. The study was funded by the Commonwealth of Pennsylvania, with additional support from NCCAM.
The researchers assigned 62 patients from a community-based cardiology practice to receive either three 600-mg capsules of red yeast rice or three placebo capsules twice daily for 24 weeks. Both groups also received lifestyle-change instruction, including information on cardiovascular disease, nutrition, exercise, and relaxation techniques. A total of 59 patients completed the study.
Compared with placebo, red yeast rice significantly decreased blood levels of LDL and total cholesterol over a 24-week period, without increasing the incidence of myalgia. Red yeast rice did not significantly affect levels of high-density lipoprotein (HDL, or “good” cholesterol), triglycerides, weight loss, or pain severity.
The study also found that red yeast rice did not significantly affect blood levels of liver enzymes or creatinine phosphokinase (CPK). This is of interest because some people who take statin drugs experience elevated liver enzymes, and because statin therapy is also associated with two rare but serious complications—myositis (muscle inflammation) and rhabdomyolysis (severe muscle breakdown)—indicated by high levels of CPK.
This was the first randomized, double-blind, placebo-controlled trial to evaluate red yeast rice in patients who cannot take statin drugs because of muscle pain. The results suggest that red yeast rice may be a cholesterol-lowering alternative for these patients, but additional, larger studies are needed to establish long-term safety and efficacy. The researchers also suggest studies to compare red yeast rice directly with statins and to explore the role of lifestyle change therapy.
Becker DJ, Gordon RY, Halbert SC, et al. Red yeast rice for dyslipidemia in statin-intolerant patients. Annals of Internal Medicine.;150(12):830–839.2009